Warranty Exclusions - Masimo RD SET Blue Instrucciones De Uso

SPECIFICATIONS
When used with Masimo SET technology, the RD SET Blue Disposable sensors have the following specifications:
Body Weight
Application Site
SpO Accuracy, No Motion
2
SpO Accuracy, No Motion
2
SpO Accuracy, No Motion
2
SpO Accuracy, Low Perfusion
2
Pulse Rate Accuracy, No Motion
Pulse Rate Accuracy, Low Perfusion
NOTE: A accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-
rms
thirds of the device measurements fell within ± A
The Blue sensor SpO accuracy has been validated using convenience blood samples from neonatal, infant, and pediatric patients with light to dark
1
2
pigmented skin diagnosed with congenital cyanotic cardiac lesions in the range of 60–100% SpO
The Masimo SET Technology has been validated for low perfusion SpO
2
100% SpO in bench top testing against a Biotek Index 2 simulator.
2
The Masimo SET Technology has been validated for pulse rate accuracy in bench top testing against a Biotek Index 2 simulator over a range of
3
25–240 bpm.
COMPATIBILITY
This sensor is intended for use only with devices containing Masimo SET oximetry or pulse oximetry monitors
licensed to use RD SET sensors. Each sensor is designed to operate correctly only on the pulse oximetry
systems from the original device manufacturer. Use of this sensor with other devices may result in no or
improper performance.
For Compatibility Information Reference: www.Masimo.com
WARRANTY
Masimo warrants to the initial buyer only that this product, when used in accordance with the directions provided with the
Products by Masimo, will be free of defects in materials and workmanship for a period of six (6) months. Single use products
are warranted for single patient use only.
THE FOREGOING IS THE SOLE AND EXCLUSIVE WARRANTY APPLICABLE TO THE PRODUCTS SOLD BY MASIMO TO BUYER.
MASIMO EXPRESSLY DISCLAIMS ALL OTHER ORAL, EXPRESS OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION
ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSE. MASIMO'S SOLE OBLIGATION AND
BUYER'S EXCLUSIVE REMEDY FOR BREACH OF ANY WARRANTY SHALL BE, AT MASIMO'S OPTION, TO REPAIR OR REPLACE
THE PRODUCT.

WARRANTY EXCLUSIONS

This warranty does not extend to any product that has been used in violation of the operating instructions supplied with the
product, or has been subject to misuse, neglect, accident or externally created damage. This warranty does not extend to
any product that has been connected to any unintended device or system, has been modified, or has been disassembled or
reassembled. This warranty does not extend to sensors or patient cables that have been reprocessed, reconditioned or recycled.
IN NO EVENT SHALL MASIMO BE LIABLE TO BUYER OR ANY OTHER PERSON FOR ANY INCIDENTAL, INDIRECT, SPECIAL OR
CONSEQUENTIAL DAMAGES (INCLUDING WITHOUT LIMITATION LOST PROFITS), EVEN IF ADVISED OF THE POSSIBILITY
THEREOF. IN NO EVENT SHALL MASIMO'S LIABILITY ARISING FROM ANY PRODUCTS SOLD TO BUYER (UNDER A
CONTRACT, WARRANTY, TORT OR OTHER CLAIM) EXCEED THE AMOUNT PAID BY BUYER FOR THE LOT OF PRODUCT(S)
INVOLVED IN SUCH CLAIM. IN NO EVENT SHALL MASIMO BE LIABLE FOR ANY DAMAGES ASSOCIATED A PRODUCT THAT
HAS BEEN REPROCESSED, RECONDITIONED OR RECYCLED. THE LIMITATIONS IN THIS SECTION SHALL NOT BE DEEMED
TO PRECLUDE ANY LIABILITY THAT, UNDER APPLICABLE PRODUCTS LIABILITY LAW, CANNOT LEGALLY BE PRECLUDED
BY CONTRACT.
NO IMPLIED LICENSE
THIS SINGLE-PATIENT SENSOR IS LICENSED TO YOU UNDER THE PATENTS OWNED BY MASIMO FOR SINGLE-PATIENT USE
ONLY. BY ACCEPTANCE OR USE OF THIS PRODUCT, YOU ACKNOWLEDGE AND AGREE THAT NO LICENSE IS GRANTED FOR
USE OF THIS PRODUCT WITH MORE THAN A SINGLE PATIENT.
AFTER SINGLE-PATIENT USE, DISCARD SENSOR.
PURCHASE OR POSSESSION OF THIS SENSOR CONFERS NO EXPRESS OR IMPLIED LICENSE TO USE THE SENSOR WITH ANY
DEVICE WHICH IS NOT SEPARATELY AUTHORIZED TO USE RD SENSORS.
, (60–80%)
1
, (70–100%)
1
, (80–100%)
1
2
3
2
of the reference measurements in a controlled study.
rms
RD SET Blue
and pulse rate accuracy with a signal strength of 0.02% over a range of 70% to
2
6
2.5–30 kg
Great Toe / Thumb
4%
3.3%
3%
3%
3 bpm
3 bpm
using a laboratory blood gas analyzer.
2
9521B-eIFU-1218